“Wilmot Cancer Institute patients with advanced melanoma (stage III) now have more options for treatment, thanks to research co-authored by a University of Rochester Medical Center surgical oncologist and published in The Lancet Oncology.

“The study involved comparing two treatment approaches for high-risk melanoma patients with a BRAF gene mutation in their cancer: standard care, which calls for upfront surgery, or giving a two-drug, targeted therapy regimen before surgery and again afterward. Patients in the latter group had longer disease-free survival in the Phase 2 trial, and after seven months researchers halted the study earlier than expected due to the positive results.”

“A majority of patients with advanced melanoma responded to the combination of pembrolizumab (Keytruda) and the investigational IDO1 inhibitor epacadostat, as reported at the European Society of Medical Oncology congress in Madrid.

“In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get.

“The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer.”

“The investigational immunotherapeutic IMC-20D7S was safe, well tolerated, and showed signs of modest clinical activity for patients with advanced melanoma, according to results from a first-in-human phase I clinical trial published in Clinical Cancer Research, a journal of the American Association for Cancer Research.

” ‘Even though immunotherapy has significantly improved outcomes for some patients with advanced melanoma, many patients have tumors that do not respond to currently available treatments or have tumors that initially respond but then become resistant to them,’ said Jedd D. Wolchok, MD, PhD, the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK) in New York. ‘In this study, we evaluated the safety and early clinical activity of a new antimelanoma immunotherapy.’ ”

“Checkpoint blockade has been a revolutionary advance in cancer treatment, supported by extensive pre-clinical and phase II/III clinical data. Recent long-term survival data suggest that immunotherapy may actually be curing some patients with advanced melanoma. In addition, potential biomarkers may help select the best immunotherapy for each patient.”

“Researchers reported two cases of demyelinating polyradiculoneuropathy after treatment with pembrolizumab (Keytruda) for advanced melanoma.

“The report, in a letter published Wednesday in the New England Journal of Medicine, raises concerns about serious, perhaps irreversible, and previously unknown adverse effects from this class of drug, which targets the PD-1 immune checkpoint pathway. These immunotherapies, offering a whole new way of attacking cancer, have generated excitement across the oncology community in recent years.

“The first patient was receiving treatment for recurrent nasal-cavity melanoma, and developed symptoms consistent with Guillain-Barré syndrome 8 weeks after beginning pembrolizumab therapy (2 mg/kg every 3 weeks), according to Philippe Saiag, MD, PhD, of Versailles Saint-Quentin-en-Yvelines University in Versailles, France, and colleagues.”

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“The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) continues to show promise, with recent data demonstrating a 26% improvement in overall survival (OS) with the 2 drugs compared with ipilimumab alone for patients with advanced melanoma.

“In a 2-year assessment of the phase II CheckMate-069 trial, which was recently presented at the 2016 AACR Annual Meeting, 142 treatment-naïve patients with unresectable stage III or metastatic stage IV melanoma were randomized to receive either the combination (n = 95) or ipilimumab plus placebo (n = 47) every 3 weeks for 4 doses followed by nivolumab or placebo every 2 weeks until disease progression or unacceptable toxicity.

“In the overall treatment population, the 2-year OS rate was 64% with the combination compared with 54% for ipilimumab alone (HR, 0.74; 95% CI, 0.43-1.26). The median OS at 2 years in patients randomized to either the combination or monotherapy has not been reached.”

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“Pembrolizumab is one of a new class of ‘checkpoint inhibitors’ touted as breakthrough therapy for advanced melanoma. In this 150-second analysis, MedPage Today clinical reviewer F. Perry Wilson, MD, MSCE breaks down the action of the drug, and synthesizes the recent efficacy data.”

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“NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.

“The independent Committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licence.

“Professor Carole Longson, Health Technology Evaluation Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.’ ”